The Agency proposes to amend these rules pursuant to HB 21 during the 2019 legislative session to delete references to hospital projects no longer subject to Certificate of Need review. Language has also been added to clarify ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NOS.:RULE TITLES:

59C-1.004Projects Subject to Review

59C-1.005Certificate of Need Exemption Procedure

59C-1.0085Project Specific Certificate of Need Application Procedures

59C-1.010Certificate of Need Application Review Procedures

59C-1.012Administrative Hearing Procedures

59C-1.021Certificate of Need Penalties

59C-1.030Criteria Used in Evaluation of Applications

PURPOSE AND EFFECT: The Agency proposes to amend these rules pursuant to HB 21 during the 2019 legislative session to delete references to hospital projects no longer subject to Certificate of Need review. Language has also been added to clarify those projects which require a Certificate of Need.

SUMMARY: The proposed changes to rules 59C-1.004, 1.005, 1.0085, 1.010, 1.012, 1.021, and 1.030, F.A.C., eliminate obsolete language and references to projects and programs that are no longer under the purview of Certificate of Need review.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 408.034, 408.033, 408.15, FS.

LAW IMPLEMENTED: 408.034, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040, 408.042, 408.044, 408.061, 408.08 FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: May 20, 2021, 2:00 p.m. to 4:00 p.m.

PLACE: No public face-to-face meeting. This hearing will be conducted via teleconference. Participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 476-211-242#. The agenda and related materials can also be found on the web at: https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Rulemaking.shtml.

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: James B. McLemore, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone].. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: James B. McLemore, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59C-1.004 Projects Subject to Review.

(1) Projects Subject to a Comparative Review. Unless subject to expedited review under Section 408.036(2), F.S., and subsection (2) of this rule, or exempted under Section 408.036(3), F.S. and Rule 59C-1.005, F.A.C., the following projects are subject to comparative review and the batching cycle procedures specified in Rule 59C-1.008, F.A.C., and will be reviewed in accordance with procedures set forth in subsection 59C-1.010(3), F.A.C.:

(a) The addition of beds in community nursing homes or intermediate care facilities for the developmentally disabled (ICF/DD) by new construction or alteration, unless exempt pursuant to Section 408.036(3) (m) (s), F.S.

(b) The new construction or establishment of additional health care facilities, including a replacement health care facility when the proposed project site is not located on the same site or within one mile of the existing health care facility, if the number of beds in each licensed bed category will not increase and unless exempt pursuant to Section 408.036(3) (j) (p), F.S.

(c) The conversion from one type of health care facility to another that requires a certificate to establish including the conversion from a general hospital, a long-term care hospital or a specialty hospital provided the conversion to a specialty hospital that is not subject to Section 395.003(8), F.S.

(d) An increase in the total licensed bed capacity for comprehensive rehabilitation unless exempt under Section 408.036(3)(j), F.S.

(d)(e) The establishment of a Hospice or Hospice inpatient facility.

(f) The establishment of inpatient tertiary health services by a health care facility.

(g) An increase in the number of beds for acute care in a hospital that is located in a low-growth county as defined in Section 408.036(1)(g), F.S.

(2) Projects Subject to Expedited Review. Unless reviewable under Section 408.036(1), F.S., above or exempted under Section 408.036(3), F.S., the following projects are subject to expedited review, and will be reviewed in accordance with procedures set forth in subsection 59C-1.010(4), F.A.C.:

(a) Sheltered nursing home beds.

(b) Transfer of a Certificate of Need except that when an existing hospital is acquired by a purchaser, all certificates of need issued to the hospital which are not yet operational shall be acquired by the purchaser, without need for a transfer.

(c) through (d) No change.

(e) Relocation of a portion of the nursing home’s licensed beds to a licensed facility or to establish a new facility within the same district, or a geographically contiguous district if the relocation is within a 30-mile radius of the existing facility and the total number of nursing home beds in the state does not increase as a result of this project.

1. Applications submitted under this paragraph must be submitted by the licensed nursing home proposing to add the beds or by the applicant proposing to establish a new facility. A letter from the facility from which the beds are being relocated must be submitted certifying that beds will be delicensed should the CON be awarded to the applicant.

2. The relocation of beds under this paragraph shall be limited to a portion of beds such that the occupancy rate of the remaining licensed beds of the facility from which beds are being relocated does not exceed 92% percent.

(f) New construction of a community nursing home in a retirement community pursuant to the provisions in Section 408.036(2)(e), F.S.

(3) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033, 408.035, 408.036(1), (2), 408.037, 408.038, 408.039 FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, Formerly 10-5.04, Amended 11-24-86, 11-17-87, 1-31-91, 1-1-92, Formerly 10-5.004, Amended 9-10-92, 1-9-95, 11-4-97, 12-12-00, 11-12-01, 8-1-05, 3-16-16,                             .

 

59C-1.005 Certificate of Need Exemption Procedure.

(1) through (5) No change.

(6) Project Specific Exemption Requests. In addition to meeting the requirements of subsections (1) and (2) of this rule, requests for exemption of certain projects must meet the additional requirements specified below:

(a) Combination within one nursing home facility of the beds authorized by two or more certificates of need issued in the same planning subdistrict. A request for exemption of a proposed combination of authorized nursing home beds shall specify:

1. The number of beds authorized by each Certificate of Need that is being combined.

2. The current holder of each Certificate of Need that is being combined.

3. The financial impact of combining the certificates of need.

4. The intended licensee for the beds included in the combined certificates of need.

5. An exemption granted under this paragraph extends the validity period of the certificates to be combined by the length of the period starting with submission of the exemption request and ending with issuance of the exemption.

6. The longest validity period among the certificates that are combined will be the validity period for the combined certificates.

7. An exemption granted under this paragraph does not authorize transfer of the combined Certificates of Need to another entity. Such transfer requires a Certificate of Need consistent with the provisions of sections 408.036(2)(a) and 408.042, F.S. and rule 59C-1.0085, F.A.C.

(b) Division into two or more nursing home facilities of the beds authorized by one Certificate of Need issued in the same planning subdistrict. A request for exemption of a proposed division of authorized nursing home beds shall specify:

1. The number of beds to be included in each component of the divided Certificate of Need.

2. The financial impact of dividing the Certificate of Need.

3. The intended licensee for the beds included in each component of a divided Certificate of Need, if known.

4. An exemption granted under this paragraph extends the validity period of the certificate to be divided by the length of the period starting with submission of the exemption request and ending with issuance of the exemption. The extension is applicable to each component of the divided Certificate of Need.

5. An exemption granted under this paragraph does not authorize transfer of the component or components of a divided Certificate of Need to another entity. Such transfer requires a Certificate of Need consistent with the provisions of sections 408.036(2)(c) and 408.042, F.S. and rule 59C-1.0085, F.A.C.

(c) Addition of comprehensive medical rehabilitation beds, licensed under chapter 395, F.S., and located within a unit of an acute care hospital or within a freestanding rehabilitation hospital in a number not exceeding 10 beds or 10% percent of the licensed capacity, whichever is greater. A request for exemption of a proposed addition of Comprehensive Medical Rehabilitation hospital beds shall specify:

1. The current number of licensed Comprehensive Medical Rehabilitation beds.

2. The exact number of beds proposed to be added.

3. Any inpatient beds of another type proposed to be delicensed or terminated in conjunction with the proposed increase.

4. The request shall certify that:

a. The average occupancy rate for the 12-month period ending 1 month prior to the exemption request meets or exceeds 80% percent. For the purpose of calculating average occupancy under this sub-subparagraph, the 12-month total of patient days shall be divided by 365 to determine an average daily census, and the average daily census shall then be divided by the total of licensed and approved beds located at the premises of the facility within the category of beds being expanded as of the end of the 12-month period. Approved beds are beds authorized for the facility consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C.

b. Any beds of the same type previously authorized for the facility by an exemption under this paragraph have been licensed and operational for at least 12 months.

5. An exemption granted under this paragraph is subject to the project monitoring requirements of sections 408.040(2)(a)-(c), F.S. and subsections 59C-1.013(2) and (3), F.A.C., including project progress reports, an 18-month validity period for the exemption, and the circumstances for extension of the validity period.

6. Beds authorized under this paragraph shall be inventoried as approved beds until the beds are licensed.

(c)(d) Addition of nursing home beds in a number not exceeding 10 beds or 10% percent of the licensed capacity of the nursing home being expanded, whichever is greater. A request for exemption of a proposed addition of nursing home beds shall specify:

1. The licensed bed capacity of the nursing home proposed to be expanded.

2. The current number of sheltered beds, if any, included within the licensed bed capacity.

3. The exact number of beds proposed to be added.

4. The number of sheltered beds, if any, proposed to be included within the total to be added.

5. The request shall certify that:

a. The facility has not had any Class I or Class II deficiencies within the 30 months preceding the request for an addition.

b. The average occupancy rate for the nursing home beds at the facility, for the 12-month period ending 1 month prior to the exemption request, meets or exceeds 94% percent. For the purpose of calculating average occupancy under this sub-subparagraph, the 12-month total of patient days shall be divided by 365 to determine an average daily census, and the average daily census shall then be divided by the total of licensed and approved beds as of the end of the 12-month period. Approved beds are beds authorized for the facility consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C.

c. Any beds previously authorized for the facility by an exemption under this paragraph have been licensed and operational for at least 12 months.

6. An exemption granted under this subparagraph is subject to the project monitoring requirements of sections 408.040(2)(a)-(c), F.S. and subsections 59C-1.013(2) and (3), F.A.C., including project progress reports, an 18-month validity period for the exemption, and the circumstances for extension of the validity period.

7. Beds authorized under this paragraph shall be inventoried as approved beds until the beds are licensed.

(d)(e) Addition of nursing home beds to a facility that has been designated as a Gold Seal nursing home under section 400.235, F.S., in a number not exceeding 20 beds or 10 percent of the licensed capacity of the nursing home being expanded, whichever is greater. A request for exemption of a proposed addition of nursing home beds shall specify:

1. The licensed bed capacity of the nursing home proposed to be expanded.

2. The current number of sheltered beds, if any, included within the licensed bed capacity.

3. The exact number of beds proposed to be added.

4. The number of sheltered beds, if any, proposed to be included within the total to be added.

5. The request shall certify that:

a. The facility has not had any Class I or Class II deficiencies within the 30 months preceding the request for an addition.

b. The average occupancy rate for the nursing home beds at the facility, for the 12-month period ending 1 month prior to the exemption request, meets or exceeds 94% percent. For the purpose of calculating average occupancy under this sub-subparagraph, the 12-month total of patient days shall be divided by 365 to determine an average daily census, and the average daily census shall then be divided by the total of licensed and approved beds as of the end of the 12-month period. Approved beds are beds authorized for the facility consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C.

c. Any beds previously authorized for the facility by an exemption under this paragraph have been licensed and operational for at least 12 months.

6. An exemption granted under this subparagraph is subject to the project monitoring requirements of sections 408.040(2)(a)-(c), F.S. and subsections 59C-1.013(2) and (3), F.A.C., including project progress reports, an 18-month validity period for the exemption, and the circumstances for extension of the validity period.

7. Beds authorized under this subparagraph shall be inventoried as approved beds until the beds are licensed.

(e)(f)  Addition of nursing home beds licensed under chapter 400, F.S., for a replacement nursing home not to exceed 30 total beds or 25 percent of the number of licensed and approved beds in the facility being replaced according to the provisions in sections 408.036(2)(b), (2)(c) or (3) (j) (p), F.S., whichever is less. A request for exemption of a proposed expansion of authorized nursing home beds must specify:

1. The licensed bed capacity of the nursing home proposed to be expanded.

2. The exact number of beds proposed to be added.

3. The subdistrict location of the facility as defined in rule 59C-2.200, F.A.C.

(g) Establishment of a Level II neonatal intensive care unit (NICU) within a licensed acute care facility if the facility can document that it has had a minimum of 1,500 births during the 12 months preceding the month the Certificate of Need exemption request was submitted and agrees to establish at least 10 Level II NICU beds. The request for exemption should specify:

1. The total licensed bed capacity of the hospital.

2. The total licensed bed capacity if the Certificate of Need exemption request is granted.

3. Applicants for exemption under this paragraph must certify that the NICU unit will provide a level of charity care or Medicaid patient days equal to or greater than the district average. The district average will be determined by averaging all Medicaid, Medicaid HMO, and charity care reported to the Florida Center for Health Information and Policy Analysis for the most recent 12-month period in which data has been certified by the Florida Center for Health Information and Policy Analysis.

a. Applicants seeking exemption under this paragraph will verify the district average with the Florida Center for Health Information and Policy Analysis and certify to provide a certain percentage of patient days to either Medicaid, including Medicaid HMO, or charity care patients or a combination of Medicaid, including Medicaid HMO, and charity care patients.

b. Applicants granted exemption under this paragraph shall report annually, pursuant to section 408.040, F.S. and rule 59C-1.013, F.A.C.

4. Applicants for exemption under this paragraph shall demonstrate that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in rule 59C-1.042, F.A.C.

a. Documentation of staffing patterns shall be submitted in a clearly organized format and certified to be correct by the applicant or its authorized representative.

b. Physical plant requirements shall be presented in a clearly organized format and certified to be correct by the applicant or its authorized representative and must indicate the establishment of at least a 10-bed unit.

c. A listing of equipment and equipment specifications should be presented and the applicant or its authorized representative must certify that listed equipment will be purchased.

d. Documentation from authorized emergency transportation providers must be presented attesting to the availability of such transportation to the applicant and certifying that it will provide emergency transportation to the applicant’s NICU patients.

(h) Establishment of a Level III Neonatal Intensive Care Unit (NICU) with at least 15 beds within a licensed acute care facility if the facility has at least a 10-bed Level II NICU and can document that it has had a minimum of 3,500 births during the 12 months preceding the month the Certificate of Need exemption request was submitted and the establishment at least 5 Level III NICU beds in an applicant hospital that is a verified trauma center pursuant to section 395.4001(14), F.S., and has a Level II neonatal intensive care unit.  A request for exemption should specify:

1. The total licensed bed capacity of the hospital.

2. The total licensed bed capacity if the Certificate of Need exemption request is granted.

3. Applicants for exemption under this paragraph must certify that the NICU unit will provide a level of charity care or Medicaid patient days equal to or greater than the district average. The district average will be determined by averaging all Medicaid, Medicaid HMO, and charity care reported to the Florida Center for Health Information and Policy Analysis for the most recent 12-month period in which data has been certified by the Florida Center for Health Information and Policy Analysis.

a. Applicants seeking exemption under this paragraph will verify the district average with the Florida Center for Health Information and Policy Analysis and certify to provide a certain percentage of patient days to either Medicaid, including Medicaid HMO, or charity care patients or a combination of Medicaid, including Medicaid HMO, and charity care patients.

b. Applicants granted exemption under this paragraph shall report annually, pursuant to section 408.040, F.S. and rule 59C-1.013, F.A.C.

4. Applicants for exemption under this paragraph shall demonstrate that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in rule 59C-1.042, F.A.C.

a. Documentation of staffing patterns shall be submitted in a clearly organized format and certified to be correct by the applicant or its authorized representative.

b. Physical plant requirements shall be presented in a clearly organized format and certified to be correct by the applicant or its authorized representative and must indicate the establishment of the unit.

c. A listing of equipment and equipment specifications should be presented and the applicant or its authorized representative must certify that listed equipment will be purchased.

d. Documentation from authorized emergency transportation providers must be presented attesting to the availability of such transportation to the applicant and certifying that it will provide emergency transportation to the applicant’s NICU patients.

(i) The addition of mental health services or beds, as defined in rule 59C-1.002, F.A.C., to licensed acute care or mental health facilities if the applicant commits to providing services to Medicaid or charity care patients at a level equal to or greater than the District average. A request for exemption of a proposed addition of mental health beds or services shall specify:

1. The licensed bed capacity of the mental health facility or unit to be expanded.

2. The current number of mental health beds by bed category as defined in rule 59C-1.002, F.A.C.

3. The exact number of beds proposed to be added.

4. The total number of mental health beds, by category, should this exemption be granted.

5. The request shall certify that the level of charity care or Medicaid patient days will be no less than the district average. The district average will be determined by averaging all Medicaid, Medicaid HMO, and charity care reported to the State Center for Health Statistics for the most recent 12-month period in which data has been cleared by the State Center for Health Statistics.

6. Mitigating evidence of compliance under this paragraph may include care provided to and state sponsored patients at a reduced rate and Baker Acted patients. Documentation to demonstrate this care shall be produced annually with the condition compliance report pursuant to section 408.040, F.S. and rule 59C-1.013, F.A.C.

7. Beds authorized under this paragraph shall be inventoried as approved beds until the beds are licensed.

8. Notification to the CON office of the conversion of beds from one type of mental health bed to another as defined in rule 59C-1.002, F.A.C., does not require a Certificate of Need exemption request and satisfies the requirements of section 408.036(5)(c), F.S.

(f)(j) The consolidation or combination of licensed nursing homes or transfer of beds between licensed nursing homes within the same planning district, by providers that operate multiple nursing homes within that same planning district, if there is no increase in the planning district total number of nursing home beds as a result of this project and the site of the relocation is not more than 30 miles from the original location. A request for exemption under this paragraph shall specify:

1. For transfer requests:

a. The name and licensed bed capacity of nursing home from which beds will be transferred.

b. The name and licensed beds capacity of the nursing home to which beds will be transferred.

c. The exact number of beds proposed to be added.

d. The total number of licensed beds at each facility should this exemption be granted.

e. The subdistrict location of each facility as defined in rule 59C-2.200, F.A.C.

f. The physical location of each facility.

2. For consolidation or combination requests:

a. The name and licensed bed capacity of each nursing home to be consolidated.

b. The name of the resulting consolidated nursing home.

c. The total number of licensed beds at the consolidated facility should this exemption be granted.

3. Verification that the providers have shared controlled interest in operating the nursing homes from which beds will either be transferred, consolidated, or combined. Certificate of Need exemption requests under this provision shall require verification that providers operate the nursing facilities in question under a common ownership or control. Verification may include copies of nursing home licenses showing common ownership or appropriate documentation that establishes the subject nursing homes are affiliates through a shared common ownership or controlling interest as defined in section 408.803(7), F.S. If Agency records indicate information inconsistent with that presented by the requesting parties, then Agency records create a rebuttable presumption as to the correctness of those records and the request for exemption will be denied.

(g)(k) The reestablishment of a health care facility or service. A request for exemption under this paragraph shall specify:

1. Documentation that the exemption applicant was previously licensed within the past 21 days as a health care facility or provider pursuant to section 408.036(1), F.S.

2. The request shall certify that the exemption applicant failed to submit a renewal application.

3. The request shall certify that the exemption applicant does not have a license denial or revocation action pending with the Agency.

4. The service type, district, service area and site for the reestablished health care facility or service.

5. If applicable, the number and type of beds for the reestablished health care facility.

6. If applicable, identify the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.

7. The request shall certify that the exemption applicant agrees to the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.

8. An exemption granted under this paragraph will expire on the 22nd day following the Agency’s approval if the exemption applicant does not apply for an initial license as required under section 408.806, F.S.

(h)(l) The establishment of a hospice program by a entity that shares a controlling interest with a not-for-profit retirement community that offers independent living, assisted living and skilled nursing services provided in facilities on the same premises as the not-for-profit retirement community. A request for exemption under this paragraph shall specify:

1. Documentation that the skilled nursing home on premise is designated by the Agency as teaching nursing home in accordance with section 430.80, F.S. and that the facility has been designated as such for at least five years prior to the exemption request.

2. Verification that the applicant and the not-for-profit retirement community and the licensed skilled nursing facility have shared controlled interest. Requests under this provision shall require verification that the providers operate the facilities under a common ownership or control. Verification may include copies of licenses as well as a copy of the certificate of authority showing common ownership or appropriate documentation that establishes the subject nursing homes are affiliates through a shared common ownership or controlling interest as defined in section 408.803(7), F.S. If Agency records indicate information inconsistent with that presented by the requesting parties, then Agency records create a rebuttable presumption as to the correctness of those records and the request for exemption will be denied.

3. The request shall certify that the exemption applicant does not operate another hospice granted under this provision.

4. The request shall certify that the exemption applicant will only serve hospice patients residing in communites located within the not-for-profit retirement community, including home and community-based service providers.

5. A service authorized under this paragraph shall be inventoried as an approved program until the service is licensed.

(7) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.036(3), (4) FS. History–New 1-1-77, Amended 6-5-79, 2-1-81, Formerly 10-5.05, Amended 11-17-87, 3-23-88, 1-31-91, Formerly 10-5.005, Amended 7-13-98, 4-2-01, 11-12-01, 8-18-05, 3-16-16, 9-24-18,                            .

 

59C-1.0085 Project Specific Certificate of Need Application Procedures for Transfer of a Certificate of Need.

In addition to the requirements set forth in Rule 59C-1.008, F.A.C., the following requirements apply to the projects described below: (1) Ttransfer of a Certificate of Need. As provided in Sections 408.037(2) and 408.034(2), F.S., an applicant for a Certificate of Need must certify that it will license and operate the health care facility or service authorized by the Certificate of Need; and the Agency will not issue a license to any health care facility, part of a health care facility, Hhospice, or health care service described in Section 408.036(1) or (2), F.S., which fails to receive a required Certificate of Need. This subsection applies to circumstances where the certificate holder will not be the initial licensee or operator of the authorized project. Such circumstances include, for example, a change in the ownership or licensed operator of the certificate holder. Except as provided in this subsection, such changed circumstances require a Certificate of Need that transfers the authorized project to the intended initial licensee or operator.

(1)(a) An application to transfer a Certificate of Need is subject to an expedited review, as specified in Section 408.036(2)(a), F.S., except that when an existing hospital is acquired by a purchaser, all certificates of need issued to the hospital which are not yet operational shall be acquired by the purchaser, without need for a transfer.

(2)(b) The proposed transferee is the applicant for the transfer. The transferor is subject to the limitations on transfer costs specified in Section 408.042, F.S., which must be identified in the application for a transfer.

(3)(c) The application fee for transfer of a Certificate of Need is $10,000 provided there is no increase in the project cost approved for the Certificate of Need that is being transferred. The filing fee for a transfer involving an increase in the project cost shall be calculated based on the amount of increase in accordance with Section 408.038, F.S. and paragraph 59C-1.008(3)(a), F.A.C.

(4)(d) A transfer application is required if the intended licensee or operator for approved nursing home beds in a combined Certificate of Need, as authorized by an exemption under Section 408.036(3) (g) (h), F.S., will be an entity other than the holder of any of the uncombined Certificates of Need.

(5)(e) A transfer application is required if the intended licensee or operator for the approved nursing home beds included in a component or components of a divided Certificate of Need, as authorized by an exemption under Section 408.036(3) (h) (i), F.S., will be an entity other than the holder of the undivided Certificate of Need.

(6)(f) A transfer application will be reviewed in accordance with the review criteria in Section 408.035, F.S.

(7)(g) Upon written request from the transferor received at least 15 days prior to the termination date of the Certificate of Need, and receipt of a transfer application, the Agency will extend the validity period of the proposed transferred Certificate of Need for a period of 60 days, consistent with paragraph 59C-1.018(3)(c), F.A.C.

(8)(h) No transfer application is required if a change in the intended initial licensee or operator of an authorized project occurs because of a corporate merger or a change in the corporate name.

(9)This rule is in effect for five years from its effective date.

(2) Conversion of licensed mental health beds. As provided in Section 408.036(5)(c), F.S., notification to the Agency is applicable for hospital projects proposing to increase the licensed capacity of a category of mental health services beds through conversion of other mental health beds at the same hospital.

(a) Mental health beds include adult and child/adolescent psychiatric beds and adult and child/adolescent substance abuse beds.

(b) Conversions under this subsection shall not increase the total licensed bed capacity of the hospital.

(3) Shared service arrangement. Any application for a project involving a shared service arrangement is subject to a comparative review when the health service being proposed requires a Certificate of Need to implement and is not currently provided by any of the applicants. Proposals for a shared service arrangement must be limited to hospitals located in the same service planning area, as defined by the Agency and applicable for the service being proposed.

(a) Each applicant jointly applying for a new health service must be a party to a formal written legal agreement.

(b) Certificate of Need approval for the shared service will authorize the applicants to provide the new health service as specified in the original application.

(c) Certificate of Need approval for the shared service shall not be construed as entitling each applicant to independently offer the new health service. Authority for any party to offer the service exists only as long as the parties participate in the provision of the shared service.

(d) Any of the parties providing a shared service may seek to dissolve the arrangement upon notice to the Agency consistent with Section 408.036(5)(l), F.S. If termination of the agreement occurs, all parties to the original shared service give up their rights to provide the service.

(e) Parties seeking to provide the service independently in the future must submit applications in the next applicable review cycle and compete for the service with all other applicants.

(f) All applicable statutory and rule criteria are met.

(4) Mobile Units.

(a) Any health care facility which intends to utilize a mobile unit must apply for a Certificate of Need prior to utilization of the mobile unit if the project has been determined subject to review by the Agency.

(b) Only a health care facility which intends to utilize a mobile unit may apply for a Certificate of Need for a mobile unit.

(5) Reestablishment of an inpatient health service regulated under this chapter. Reestablishment of a health service which was not offered continuously at a health care facility for the 12-month period prior to the proposed reestablishment is a substantial change in health services, and requires a Certificate of Need.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033, 408.034, 408.036(2), 408.037(3), 408.038, 408.039, 408.042 FS. History–New 1-31-91, Formerly 10-5.0085, Amended 10-18-95, 10-8-97, 12-12-00, 7-19-05,                       .

 

59C-1.010 Certificate of Need Application Review Procedures.

(1) The Agency shall review all applications in the context of the review criteria specified in Section 408.035, F.S. and Chapters 59C-1 and 59C-2, F.A.C., and all information relevant to the criteria contained therein.

(2) General Provisions.

(a) Applications subject to comparative or expedited review shall be submitted to the Agency on AHCA Form 3150-0001, August 2020 March 2009 “Application For A Certificate of Need” or 3150-0003, August 2020 March 2009 “Transfer of A Certificate of Need” or 3150-0002, March 2009 Application For A General Hospital Certificate of Need, as referenced in paragraph 59C-1.008(1)(f), F.A.C.

(b) Applications for projects involving an existing health care facility shall be filed by the current license holder as listed on the current Agency license in effect at the time of the applicant omission deadline specified in subparagraphs (3)(a)3. or (4)(d)3. of this rule, or the application shall be withdrawn from consideration. Applications submitted by corporations required to have filed incorporation papers or foreign corporation papers in order to do business in Florida must be able to do business in Florida prior to notifying the Agency of its intentions in a comparative review cycle or by the time it files an expedited application, if the project is subject to expedited review.

(c) An application shall not be deemed complete by the Agency unless all information required by statute and rule has been submitted by the applicant.

(d) An application for a general hospital must meet the requirements of Sections 408.035(2) and 408.037(2), F.S.

(3) No change.

(4) Expedited Review. Applications subject to expedited review shall be reviewed according to the following timetable:

(a) through (d) no change.

(e) The Agency shall deem the application complete or withdrawn within seven 7 calendar days of the receipt of the requested information. Subsequent to an application being deemed complete by the Agency, no further application information or amendment will be accepted by the Agency, unless a statutorily required item was omitted and the Agency failed to clearly request the specific item in its omissions request. In the later case, the application may be supplemented only with the omitted item.

(f) through (g) No change.

(5) Issuance of State Agency Action Report.

(a) The Agency shall issue a State Agency Action Report describing the Agency’s findings for each application deemed complete. All applications that were comparatively reviewed shall be described in a single State Agency Action Report. The report shall state the Agency’s intent to grant or deny certificates of need for projects in their entirety or for identifiable portions thereof, and state the conditions required of the Certificate of Need holder, if any. The Agency Secretary or their his designee shall sign State Agency Action Reports. The Agency shall publish its notice of intent, as set forth in the State Agency Action Report, in the F.A.R. within 14 calendar days after the State Agency Action Report is issued. A notice of intent and State Agency Action Report shall be mailed to each applicant. The Agency decision embodied in the State Agency Action Report to grant additional beds, services, or programs will be reflected in the Agency’s inventories.

(b) If there is no challenge to all or any part of the Agency decision embodied in the State Agency Action Report within 21 days after the publication of the notice of intent, consistent with Rule 59C-1.012, F.A.C., the State Agency Action Report shall become the final order of the Agency. The Certificate of Need shall be signed by the Secretary of the Agency or their his designee and shall become effective on the date when the final order is filed in the Office of the Agency Clerk.

(c) If a request for an Administrative Hearing is filed timely, and a final order is subsequently entered which grants a Certificate of Need in whole or in part, a Certificate of Need shall be signed by the Secretary of the Agency or their his designee. The Certificate of Need shall become effective on the date when the final order is filed in the Office of the Agency Clerk. The Agency shall provide a copy of the final order to the local health councils.

(d) The Agency shall issue a Certificate of Need according to the timeframes specified in subsections (3) or (4) of this rule, specifying the scope of the project, any conditions placed on the Certificate of Need, and an approved dollar amount for the project in its entirety or for identifiable portions of the total project; or the Agency shall deny a Certificate of Need for the project in its entirety. The Agency may impose conditions on a Certificate of Need predicated upon statements of intent expressed by an applicant in the Certificate of Need application, which the Agency relied upon in its decision to issue the Certificate of Need, and which relate to the criteria set forth in Section 408.035, F.S. and Chapters 59C-1 and 59C-2, F.A.C.

(6) through (7) No change.

(8) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033(1), 408.035(2), 408.036(2), 408.037(2), 408.039(3), (4), (5) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 12-23-82, Formerly 10-5.10, Amended 11-24-86, 11-17-87, 3-23-88, 8-28-88, 1-31-91, 7-1-92, 7-14-92, Formerly 10-5.010, Amended 10-8-97, 12-12-00, 4-2-01, 6-23-05, 4-21-10,                          .

 

59C-1.012 Administrative Hearing Procedures.

(1) No change.

(2)(a) If a valid request for Administrative Hearing is timely filed challenging the noticed intended award of any Certificate of Need application in the batch, that challenged granted applicant shall have ten days from the date the notice of litigation is published in the Florida Administrative Register to file a petition challenging any or all other cobatched applications.

(a)(b) If no valid request for Administrative Hearing is timely filed challenging the noticed intended award of a Certificate of Need to an applicant, there is no pending challenge to the applicable published Fixed Need Pool projection, and there has been no petition filed pursuant to paragraph (2)(a), the noticed intended granted application shall be severed from the rest of the batch and become final Agency action with respect to such application. If there are pending challenges to the applicable published Fixed Need Pool projection, no noticed intended granted application can be severed from the batch and become final Agency Action, unless the application is withdrawn.

(b)(c) If all requests for Administrative Hearings challenging a noticed intended award of a CON, and all challenges to the relevant published Fixed Need Pool projection, if any, are subsequently voluntarily dismissed, the unchallenged noticed intended granted application shall be severed from the remainder of the batch and the noticed intended award shall become final Agency action with respect to such applicant. If there remain any pending challenges to the applicable published Fixed Need Pool projection, no noticed intended granted application can be severed from the batch and become final Agency Action, unless the application is withdrawn.

(c)(d) For purposes of comparative hearing on any remaining applications in the batch, the beds or services awarded to unchallenged noticed intended granted applications in the batch which have become final Agency Action shall automatically be subtracted from the unchallenged numeric Fixed Need Pool projection applicable to the batch, even if the projection is zero, and it shall be conclusively presumed that the award of Beds or Services in the batch which have become final Agency action will become operative in the service area in accordance with the representations contained in the Certificate of Need application leading to approval.

(e) The party appealing a final order that grants a general hospital Certificate of Need shall post a $1 million bond as directed in Section 408.039(6)(d), F.S. The bond must be made payable to the appellee or appellees and must reference the appealing party, the CON number being appealed, and the Division of Administrative Hearings (DOAH) case number. The bond needs to be sent to:

Agency for Health Care Administration

Attention: Agency Clerk

2727 Mahan Drive, MS #3

Tallahassee, Florida 32308

(3) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.039(5), (6) FS. History–New 1-1-77, Amended 9-1-78, 6-5-79, 10-23-79, 4-25-80, Formerly 10-5.12, Amended 11-24-86, 11-17-87, Formerly 10-5.012, Amended 12-14-92, 4-21-10,        .

 

59C-1.021 Certificate of Need Penalties.

(1) through (2) No change.

(3) Penalties for Failure to Comply with Certificate of Need or Exemption Conditions. The Agency shall review the annual compliance report submitted by the health care providers who are licensed and operate the facilities or services and other pertinent data to assess compliance with Certificate of Need or exemption conditions. Providers who are not in compliance with Certificate of Need or exemption conditions shall be fined. Failure to report compliance with any condition upon which the issuance of the Certificate of Need or exemption was predicated constitutes noncompliance. For community nursing homes or hospital-based skilled nursing units certified as such by Medicare, the first compliance report on the status of conditions must be submitted 30 calendar days following the eighteenth month of operation or the first month where an 85% percent occupancy is achieved, whichever comes first. The schedule of fines is as follows:

(a) Facilities failing to comply with any conditions or failing to provide the Certificate of Need office with a report on its compliance with conditions set forth on the Certificate of Need or exemption, will be assessed a fine, not to exceed $1,000 per failure per day. In assessing the penalty the Agency shall take into account the degree of noncompliance.

(b) The assessed fine shall be paid to the Agency within 45 calendar days after written notification of assessment by certified mail or within 30 calendar days after final Agency action if an Administrative Hearing has been requested. If a health care provider desires it may remit payment according to a payment schedule accepted by the Agency. The health care provider must submit the schedule of payments to the Agency within 30 calendar days after the date of receipt of the notification of assessment or 21 calendar days after final Agency Action. The final balance will be due no later than six 6 months after the health care provider has been notified in writing by the Agency of the amount of the assessed fine or six 6 months after final Agency Action.

(4) no change.

(5) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.040(2)(a), 408.034(8), 408.15(8) FS. Law Implemented 408.034(5), (8) 408.040(1)(b), (d), (2)(a), 408.044, 408.061(6), 408.08(2) FS. History–New 7-25-89, Formerly 10-5.021, Amended 12-13-04,_____.

 

59C-1.030 Criteria Used in Evaluation of Applications.

In addition to criteria set forth in Section 408.035, F.S., the following health care access criteria are used in the review of an application.

(1) For a new general hospital as defined in Section 395.002, F.S. and subparagraphs 59A-3.252(1)(a)1. and 3., F.A.C., the criteria for evaluation are those found in Sections 408.035(2) and 408.037(2), F.S.

(2) Health Care Access Criteria.

(1)(a) The need that the population served or to be served has for the health or Hospice services proposed to be offered or changed, and the extent to which all residents of the district, and in particular low income persons, racial and ethnic minorities, women, handicapped persons, other underserved groups and the elderly, are likely to have access to those services.

(2)(b) The extent to which that need will be met adequately under a proposed reduction, elimination or relocation of a service, under a proposed substantial change in admissions policies or practices, or by alternative arrangements, and the effect of the proposed change on the ability of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services to obtain needed health care.

(3)(c) The contribution of the proposed service in meeting the health needs of members of such medically underserved groups, particularly those needs identified in the applicable local health plan and State health plan as deserving of priority.

(4)(d) In determining the extent to which a proposed service will be accessible, the following will be considered:

(a)1. The extent to which medically underserved individuals currently use the applicant’s services, as a proportion of the medically underserved population in the applicant’s proposed service area(s), and the extent to which medically underserved individuals are expected to use the proposed services, if approved;

(b)2. The performance of the applicant in meeting any applicable Federal regulations requiring uncompensated care, community service, or access by minorities and handicapped persons to programs receiving Federal financial assistance, including the existence of any civil rights access complaints against the applicant;

(c)3. The extent to which Medicare, Medicaid and medically indigent patients are served by the applicant; and,

(d)4. The extent to which the applicant offers a range of means by which a person will have access to its services.

(5)(e) In any case where it is determined that an approved project does not satisfy the criteria specified in paragraphs (1) (a) through (4) (d), the Agency may, if it approves the application, impose the condition that the applicant must take affirmative steps to meet those criteria.

(6)(f) In evaluating the accessibility of a proposed project, the accessibility of the current facility as a whole must be taken into consideration. If the proposed project is disapproved because it fails to meet the need and access criteria specified herein, the Agency Department will so state in its written findings.

(7) This rule is in effect for five years from its effective date.

Rulemaking Authority 408.15(8), 408.034(3), (8) FS. Law Implemented 408.035, 408.037 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(a), (b), 10-5.030, Amended 4-21-10,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: James B. McLemore

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Simone Marstiller

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 02, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 10/31/2019